Cleared Traditional

K233342 - CINA-ASPECTS (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233342 · Avicenna.Ai · Radiology device
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Mar 2024
Decision
168d
Days
Class 2
Risk

K233342 is an FDA 510(k) clearance for the CINA-ASPECTS. Classified as Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer (product code POK), Class II - Special Controls.

Submitted by Avicenna.Ai (La Ciotat, FR). The FDA issued a Cleared decision on March 15, 2024 after a review of 168 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2060 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K233342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2023
Decision Date March 15, 2024
Days to Decision 168 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 107d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code POK Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2060
Definition Assist Users In Characterizing Lesions Identified On Acquired Medical Images
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
John J. Smith

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - POK Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer

All 20
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